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Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

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Surveillance of Pharmaceutical Risk-Mitigation Behavior: Applying and Comparing Statistical Process Control Methods

Harris Butler1,2, John D Rice1,3, Nichole E Carlson1

  • 1Department of Biostatistics and Informatics University of Colorado Anschutz Medical Campus Aurora Colorado USA.

Learning Health Systems
|June 10, 2026
PubMed
Summary
This summary is machine-generated.

A new statistical process control (SPC) method effectively monitors prescribing behavior for high-risk drugs. This advanced surveillance tool detects changes earlier than traditional methods, aiding in drug safety and risk management.

Keywords:
FDAREMSadministrative claims datamisspecificationpharmacovigilancereal‐world datarisk mitigationstatistical process controlsurveillance

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Area of Science:

  • Pharmacovigilance
  • Health Services Research
  • Biostatistics

Background:

  • Post-marketing surveillance of high-risk medications is crucial for identifying safety issues.
  • Current surveillance methods using real-world data are underdeveloped.
  • Administrative claims data offers a valuable resource for monitoring prescribing patterns.

Purpose of the Study:

  • To evaluate a modified statistical process control (SPC) method for post-marketing surveillance of risk minimization measures.
  • To assess the method's ability to detect changes in population-level prescribing behaviors using administrative claims data.
  • To compare the modified SPC method with a classical SPC approach for drug safety surveillance.

Main Methods:

  • Utilized Colorado All-Payers Claims Database (2012-2019) for tapentadol extended release (ER) prescriptions.
  • Developed a modified SPC method monitoring model misspecification, establishing a baseline from 2012 data.
  • Compared modified SPC with classical SPC, controlling false alarm rates, and aligned detections with policy actions.

Main Results:

  • The modified SPC method detected two periods of unusual prescribing behavior (March 2015, April 2016).
  • The classical SPC method detected only one period (October 2016), six months after the second modified SPC detection.
  • Modified SPC detections better aligned temporally with risk minimization activities.

Conclusions:

  • The modified SPC method offers improved detection of prescribing behavior changes compared to classical SPC.
  • This tool can assist regulatory agencies in independently monitoring emerging drug risks and prescribing trends.
  • The method complements Risk Evaluation and Mitigation Strategies (REMS) assessments by providing timely insights.